Tuesday, 24 April 2018

Pharmaceutics book: Handbook of Bioequivalence Testing

  • Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations
  • Discusses worldwide regulatory requirements for filing for approval of generic drugs
  • Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification
  • Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects
  • Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations
  • Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies
Click here to view the book
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